Back to resultsA Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ASP1941
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring ASP1941, Diabetes mellitus, Blood glucose
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetic patients for at least 12 weeks
- HbA1c value between 7.0 and 10.0% at screening
- Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2.
Exclusion Criteria:
- Type 1 diabetes mellitus patients
- Serum creatinine > upper limit of normal
- Proteinuria（albumin/creatinine ratio > 300mg/g）
- Dysuria and/or urinary tract infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ASP1941 high dose group
ASP1941 low dose group
Placebo group
Arm Description
oral
oral
oral
Outcomes
Primary Outcome Measures
Change in plasma glucose levels
Secondary Outcome Measures
Urinary glucose excursion
Pharmacokinetic parameter of ASP1941
Safety by adverse events, routine safety laboratories and vital signs.
Change in serum insulin levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01023945
Brief Title
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Official Title
A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 7, 2009 (Actual)
Primary Completion Date
March 26, 2010 (Actual)
Study Completion Date
March 26, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
ASP1941, Diabetes mellitus, Blood glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP1941 high dose group
Arm Type
Experimental
Arm Description
oral
Arm Title
ASP1941 low dose group
Arm Type
Experimental
Arm Description
oral
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
ASP1941
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change in plasma glucose levels
Time Frame
On day 14
Secondary Outcome Measure Information:
Title
Urinary glucose excursion
Time Frame
On day 14
Title
Pharmacokinetic parameter of ASP1941
Time Frame
On day 14
Title
Safety by adverse events, routine safety laboratories and vital signs.
Time Frame
During treatment
Title
Change in serum insulin levels
Time Frame
On day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetic patients for at least 12 weeks
HbA1c value between 7.0 and 10.0% at screening
Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
Body Mass Index (BMI) 20.0 - 45.0 kg/m2.
Exclusion Criteria:
Type 1 diabetes mellitus patients
Serum creatinine > upper limit of normal
Proteinuria（albumin/creatinine ratio > 300mg/g）
Dysuria and/or urinary tract infection
Significant renal, hepatic or cardiovascular diseases
Severe gastrointestinal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Kantou
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Citations:
PubMed Identifier
32839028
Citation
Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=90
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
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